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Alhemo® (concizumab-mtci) injection 60 mg, 150 mg, or 300 mg is indicated for routine
prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric
patients 12 years of age and older with hemophilia A or B with or without Factor VIII or IX
inhibitors.
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Demonstrated efficacy in hemophilia B and A
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Powerful everyday bleed protection for patients with hemophilia B or A1,2
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Adherence to daily dosing of Alhemo® is important to maintain protection against bleeding.
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Primary Endpoint: The estimated mean ABR ratio in patients with hemophilia B was 0.21 (P<0.001)
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In patients with Hemophilia B, Alhemo® for prophylaxis reduced treated spontaneous and traumatic bleeds by 79% vs. on-demand FIX treatment.
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Study design: explorer8 was a phase 3, open-label study evaluating Alhemo® for routine PPx in
118 adult (67 HA and 51 HB) and 38 adolescent (23 HA and 15 HB) males. Efficacy was evaluated
separately in HA and HB when patients previously treated on demand in arms 1 (no PPx; on-demand
factor replacement) and 2 (Alhemo® PPx) had completed the main part of the trial (at least 24 or
at least 32 weeks, respectively), based on the number of treated bleeding episodes, comparing
Alhemo® PPx with on-demand factor. Ratio of the ABR was estimated using a negative binomial
model.1
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In HA, using a negative binomial model, a ratio of the ABR was estimated to 0.14 (P<0.001),
corresponding to a reduction in ABR of 86% for patients on Alhemo® PPx compared with on-demand
FVIII. The mean ABR was 2.7 [95% CI: 1.63; 4.59] for patients on Alhemo® PPx (arm 2) and 19.3
[95% CI: 11.25; 33.03] for patients on on-demand FVIII (arm 1).1
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Alhemo® is delivered via a prefilled, subcutaneous pen—designed to transform how
patients administer treatment.1,a,b
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aAlhemo® is intended for use under the guidance of a healthcare provider
and may be self-administered or administered by a caregiver after appropriate training and
reading the Instructions for Use if a healthcare provider determines that is appropriate.
bNeedles sold separately and may require a prescription in some states. New needle is
required for each injection.
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Personalized protection with an optimized/individualized dose
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The Alhemo® dosing tool makes it easy to individualize prophylaxis dosing for each patient—helping you tailor treatment to their unique needs.
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| Keep scrolling to learn more about
Alhemo® |
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| Important Safety Information |
| Contraindications |
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Alhemo® is contraindicated in patients with a history of known serious hypersensitivity to Alhemo® or its ingredients |
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| Warnings and Precautions |
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| Thromboembolic Events (TEs): Venous and arterial TEs were reported in 1.9% of patients (6/320) who also had multiple risk factors, including the use of high doses or prolonged treatment with factor product or bypassing agent (2 of 6 patients). Risk factors for TEs may also include conditions in which tissue factor is overexpressed (eg, atherosclerotic disease, crush injury, cancer, disseminated intravascular coagulation, thrombotic microangiopathy, or septicemia). Inform patients about and monitor them for signs and symptoms of TEs. In case of suspicion of TEs, discontinue Alhemo® and initiate further investigations and management strategies |
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| Please click here or scroll below for additional Important Safety Information. |
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Have questions?
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| Connect with a Novo Nordisk Rare Blood Therapy Manager in your area. They can help you with: |
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Clinical product information |
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Rare bleeding education for patients |
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Resources for starting treatment |
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| Indications and Usage for Alhemo® |
| Alhemo® (concizumab-mtci) injection 60 mg, 150 mg, or 300 mg is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A or B with or without Factor VIII or IX inhibitors. |
| Important Safety Information (cont’d) |
| Warnings and Precautions (cont'd) |
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| Hypersensitivity Reactions: Alhemo® is contraindicated in patients with a history of known serious hypersensitivity to Alhemo® or its ingredients. Hypersensitivity reactions, including erythema, rash, pruritus, and abdominal pain, have occurred in patients treated with Alhemo®. One patient (<1%) experienced anaphylaxis, which resolved after treatment with antihistamines and corticosteroids. Instruct patients of the signs of acute hypersensitivity reactions and to contact their healthcare provider for mild reactions and to seek urgent medical attention for moderate to severe reactions. Discontinue Alhemo® if severe hypersensitivity symptoms occur and initiate medical management |
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| Increased Laboratory Values of Fibrin D-dimer and Prothrombin Fragment 1.2: Increased levels of fibrin D-dimer and prothrombin fragment 1.2 were seen in 29 (9.1%) and 26 (8.1%) patients, respectively, which is positively correlated with the plasma concentration of concizumab-mtci, indicating a hemostatic effect. For patients taking Alhemo®, these coagulation biomarkers may not be reliable predictive markers for clinical decision-making with suspicion of thrombosis, such as deep vein thrombosis and pulmonary embolism |
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| Adverse Reactions |
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The most frequently reported adverse reactions (≥5%) were injection site reactions, headache, and urticaria |
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Serious adverse reactions were reported in 6.1% of patients with inhibitors who received Alhemo®. Permanent discontinuation of Alhemo® occurred in 1 patient due to a renal infarct and dosage interruptions of Alhemo® occurred in 1 patient (3%) and was a hypersensitivity reaction |
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| Drug Interactions |
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Breakthrough Bleeding Treatment: Take appropriate precautions when treating breakthrough bleeding events in patients receiving Alhemo® prophylaxis and FVIII or FIX or a bypassing agent (eg, rFVIIa or aPCC). For mild and moderate bleeds, the lowest approved dose in the approved product labeling is recommended. For aPCC, a maximum dose of 100 units/kg within 24 hours is recommended. For severe bleeds, follow the dosing instructions in the approved labeling based on clinical judgment |
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| Please click here for Prescribing Information. |
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References:
| 1. |
Alhemo [Prescribing Information]. Novo Nordisk Inc. |
| 2. |
Chowdary P, Angchaisuksiri P, Apte S, et al. Concizumab prophylaxis in people with haemophilia A or haemophilia B without inhibitors (explorer8): a prospective, multicentre, open-label, randomised, phase 3a trial. Lancet Haematol. 2024;11(12):e891-e904. |
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